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NCT04786093 · ClinicalTrials.gov registry record · Phase 2
Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT04786093: Active Phase 2 study of Non-Small Cell Lung Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT04786093 is a Phase 2 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 52 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04786093, a Phase 2 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized Phase II study which is designed to determine the impact of stereotactic radiotherapy and durvalumab on quality-of-life and oncologic outcomes in patients with advanced non-small cell lung cancer. Durvalumab (Imfinzi) and stereotactic radiotherapy, with each fraction of radiotherapy is given every other day on a standard stereotactic ablative radiotherapy (SAbR) schedule or every four weeks on the personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) schedule. Subjects will be followed for a period of 2 years after completion of treatment or until death, whichever occurs first. Specifically, subjects will be followed at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months following treatment. After the 2 year follow up, the patient can continue routine follow up with their physicians, per standard of care. Subjects removed from therapy for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Primary Outcome
To assess the impact of durvalumab and stereotactic radiotherapy, in the form of stereotactic ablative radiotherapy (SAbR) or personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR), on improving QoL (quality of life) in patients with metastatic non-small cell lung cancer using the European organization for Research and treatment of cancer questionnaire (EORTC-QLQ30). The score range is 0-100. Higher the score, the better the results.
Conditions Studied
Interventions
- DRUG Durvalumab
- RADIATION Stereotactic radiation therapy
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-07-27 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What the registry record for NCT04786093 still lists
NCT04786093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT04786093 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04786093 about?
NCT04786093 is a clinical study titled "Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC". This is a randomized Phase II study which is designed to determine the impact of stereotactic radiotherapy and durvalumab on quality-of-life and oncologic outcomes in patients with advanced non-small cell lung cancer. Durvalumab (Imfinzi) and stereotactic radiotherapy, with each fraction of radiothe...
What is the current status of trial NCT04786093?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2021-07-27. Estimated completion is 2027-05.
What conditions does trial NCT04786093 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04786093?
The interventions under investigation include: Durvalumab (DRUG), Stereotactic radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT04786093?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04786093 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04786093's enrollment target sits among peer trials
52 330th of 454 higher than 122 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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